诺氟沙星片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.60对照品水分(%)0对照品稀释倍数100
标示量(mg)100 供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.813930908393944139394903933334393410039354550.10
29.823935773394133239385520.10
单位质量响应值RSD%判断
401167.69401074.540.02数据可信
供试品溶液-E001批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14029981-402998190.05989.956.8590.0689.956.85
24038243-403824390.24490.24
34161328-416132892.99592.99
44093380-409338091.47691.48
54320720-432072096.55796.56
63506888-350688878.37078.37
10min14439881-443988199.22099.281.8799.3799.431.87
24335671-433567196.89197.04
34350402-435040297.22097.38
44530786-4530786101.251101.40
54488958-4488958100.316100.48
64510280-4510280100.793100.92
15min14457289-445728999.60999.231.7699.9299.551.75
24323398-432339896.61796.93
34365839-436583997.56597.88
44516023-4516023100.921101.24
54483302-4483302100.190100.52
64496845-4496845100.493100.79
20min14457582-445758299.61599.131.75100.1099.611.75
24325590-432559096.66697.14
34352946-435294697.27797.76
44510757-4510757100.804101.29
54470919-447091999.913100.41
64497336-4497336100.504100.97
30min14418990-441899098.75398.772.0499.4099.422.03
24306507-430650796.23996.87
34317547-431754796.48697.13
44516141-4516141100.924101.58
54463032-446303299.737100.40
64497349-4497349100.504101.14
诺氟沙星片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.60对照品水分(%)0对照品稀释倍数100
标示量(mg)100 供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.813934887394341039352483933262393501039363630.11
29.823919860390811839139890.22
单位质量响应值RSD%判断
401260.24398573.220.48数据可信
供试品溶液-E001批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14009465-400946589.87291.173.2089.8791.173.20
24062587-406258791.06391.06
34165119-416511993.36193.36
44040396-404039690.56590.57
54252186-425218695.31295.31
63875725-387572586.87486.87
10min14382948-438294898.24399.711.7498.3999.861.74
24393533-439353398.48198.63
34565637-4565637102.338102.49
44374349-437434998.05198.20
54497499-4497499100.811100.97
64477471-4477471100.362100.51
15min14414253-441425398.94599.731.7599.26100.051.75
24354782-435478297.61297.93
34549409-4549409101.975102.30
44379497-437949798.16698.48
54508642-4508642101.061101.39
64488230-4488230100.603100.92
20min14400201-440020198.63099.941.5099.11100.431.49
24487785-4487785100.593101.07
34543390-4543390101.840102.34
44360419-436041997.73898.22
54476206-4476206100.334100.83
64484855-4484855100.528101.01
30min14398491-439849198.59299.531.5099.23100.181.50
24380316-438031698.18498.83
34535469-4535469101.662102.33
44371051-437105197.97798.62
54475077-4475077100.308100.97
64481083-4481083100.443101.09
诺氟沙星片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.60对照品水分(%)0对照品稀释倍数100
标示量(mg)100 供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.813936241393104339225693917555392530139265420.19
29.823938822393026739345440.16
单位质量响应值RSD%判断
400259.12400666.400.08数据可信
供试品溶液-E001批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13997132-399713289.47287.044.2689.4787.044.26
23591934-359193480.40280.40
34080124-408012491.33091.33
43876294-387629486.76786.77
53892091-389209187.12187.12
63893992-389399287.16487.16
10min14332609-433260996.98297.631.6497.1397.781.63
24405312-440531298.60998.74
34356890-435689097.52597.68
44480433-4480433100.291100.44
54308309-430830996.43896.58
64286525-428652595.95096.10
15min14331111-433111196.94897.441.2597.2697.741.24
24383975-438397598.13198.43
34363101-436310197.66497.98
44437924-443792499.33999.65
54313969-431396996.56496.87
64287296-428729695.96796.27
20min14273020-427302095.64897.241.5496.1297.711.53
24359979-435997997.59498.06
34332440-433244096.97897.46
44466942-446694299.989100.47
54312126-431212696.52396.99
64320405-432040596.70897.17
30min14340318-434031897.15497.540.9097.7998.170.90
24415318-441531898.83399.46
34351643-435164397.40898.05
44392378-439237898.31998.96
54334251-433425197.01897.65
64310267-431026796.48197.11
诺氟沙星片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.60对照品水分(%)0对照品稀释倍数100
标示量(mg)100 供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.813937224391643139305203927239393346339289750.21
29.823905204391567739104400.19
单位质量响应值RSD%判断
400507.14398211.810.41数据可信
供试品溶液-E001批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14102853-410285392.09390.903.4792.0990.903.47
24079963-407996391.57991.58
33768101-376810184.57984.58
44144879-414487993.03693.04
54120961-412096192.50092.50
64081171-408117191.60691.61
10min14414861-441486199.09797.391.3199.2597.541.31
24295500-429550096.41796.57
34280649-428064996.08496.22
44340158-434015897.42097.57
54398211-439821198.72398.88
64302367-430236796.57196.72
15min14433436-443343699.51397.991.6699.8398.311.66
24272950-427295095.91196.22
34295879-429587996.42696.73
44351581-435158197.67697.99
54389823-438982398.53598.85
64450944-445094499.906100.22
20min14438693-443869399.63198.161.35100.1298.641.35
24300673-430067396.53397.01
34302730-430273096.58097.04
44375487-437548798.21398.69
54407538-440753898.93299.42
64413895-441389599.07599.55
30min14420294-442029499.21897.471.2299.8798.121.21
24271812-427181295.88696.52
34317886-431788696.92097.54
44363254-436325497.93898.58
54370705-437070598.10598.75
64311650-431165096.78097.43
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